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The study aims to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting.
A total of 13 breast cancer patients referred to our clinic for curative radiotherapy were recruited for this pilot study. The women were supposed to undertake a "Paleolithic lifestyle" (PL) intervention consisting of a Paleolithic diet and daily outdoor activity of at least 30 min duration while undergoing radiotherapy. Body composition was measured weekly by bioimpedance analysis. Blood parameters were assessed before, during, and at the end of radiotherapy. A control group on an unspecified standard diet (SD) was assigned by propensity score matching.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paleolithic lifestyle group | Experimental | The Paleolithic lifestyle (PL) intervention during radiotherapy consists of daily outdoor walks or bike rides of at least 30 min duration, preferably done at noon to maximize vitamin D production, and the adoption of a Paleolithic diet. For the outdoor activity, patients were told to not use sun screen. The Paleolithic diet prescription emphasized the consumption of fatty meats and organ meats from humanely raised animals, wild-caught fish, eggs, nuts and seeds, algae, spices, vegetables and fruits. Excluded were processed foods, grains of all types, legumes, vegetable oils except for native coconut and olive oil and dairy products except for ghee. No dietary supplements were allowed. Patients were supposed to start the PL intervention at least two days prior to the first irradiation and to protocol their food consumption on two days during the first week on the diet. They were also asked about their compliance to the PL intervention at each weekly measurement appointment. |
|
| Standard diet group | Other | This group is on a standard diet while receiving radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curative radiotherapy | Radiation | Standard curative radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dropout rate in the Paleolithic lifestyle intervention group | Used to measure feasibility. The intervention is rated as feasible if dropout rate is <30% | through study completion, an average of 5 weeks |
| Longitudinal body composition changes | Measured on a bioimpedance scale (seca mBCA, seca Deutschland, Hamburg, Germany) | through study completion, an average of 5 weeks |
| Change in vitamin D levels | Difference between final (average 5 weekks) and baseline 25-hydroxyvitamin D level | through study completion, an average of 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in beta-hydroxybutyrate levels | Change between baseline and final (average 5 weeks) beta-hydroxybutyrate levels | through study completion, an average of 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology | Schweinfurt | Bavaria | 97421 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33247817 | Result | Klement RJ, Koebrunner PS, Krage K, Weigel MM, Sweeney RA. Short-term effects of a Paleolithic lifestyle intervention in breast cancer patients undergoing radiotherapy: a pilot and feasibility study. Med Oncol. 2020 Nov 28;38(1):1. doi: 10.1007/s12032-020-01443-0. |
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Will be made available upon reasonable request. Plan is also to publish all data of this and the KETOCOMP study (NCT02516501) together as soon as all analyses have been published.
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The data can be requested from now on.
A reasonable request to the study P.I. (Dr. Klement) suffices.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001836 | Body Weight Changes |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Paleolithic lifestyle intervention | Other | This intervention consists of daily outdoor walks or bike rides of at least 30 min duration, preferably done at noon to maximize vitamin D production, and the adoption of a Paleolithic diet. For the outdoor activity, patients were told to not use sun screen. The Paleolithic diet prescription emphasized the consumption of fatty meats and organ meats from humanely raised animals, wild-caught fish, eggs, nuts and seeds, algae, spices, vegetables and fruits. Excluded were processed foods, grains of all types, legumes, vegetable oils except for native coconut and olive oil and dairy products except for ghee. No dietary supplements were allowed. |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |